MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® TOUCHLESS® PLUS UNISEX PRE-LUBRICATED VINYL URETHRAL CATHETER; TOUCHLESS PLUS CATHETER

Model Number	4A6144
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Codes	Burn(s) (1757); Hemorrhage/Blood Loss/Bleeding (1888); Irritability (2421); Skin Inflammation/ Irritation (4545); Urinary Incontinence (4572)
Date of Event	05/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
Event or Problem Description
It was reported that intermittent catheter had holes in the tip of the catheters and not been fully punched out which leaves a flap that drags along the inner side of the urethra.Customer experienced irritation in the urethra and problems with urination.No medical intervention was reported.Per follow up on (b)(6) 2021, patient had small amount of bleeding, incontinence and burning.Patient did not used one of the defective catheters in almost a week now.No medical intervention was reported.
Additional Manufacturer Narrative
The reported event was unconfirmed as the problem could not be reproduced.The device had met relevant specifications.The product was used for treatment.The product did not caused the reported failure.Visual evaluation of the returned sample noted one opened (with original packaging) used touchless catheter.Visual inspection of the sample noted no obvious visible defects.The eyelets were present and smooth with no burrs or flash.A potential root cause for this failure mode could be due to the reported issue was unconfirmed.The investigation indicated that the reported issue was not manufacturing or supplier related.Therefore a device history record review was not required.Per investigation a labeling review was not required due to the reported issue was unconfirmed.Correction: d, e.H11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : the actual/suspected device was inspected.
Event or Problem Description
It was reported that the intermittent catheters had holes in the tip of the catheters and were not fully punched out which leaves a flap that drags along the inside of the urethra.The customer experienced irritation in the urethra and problems with urination.No medical intervention was reported.Per follow up on (b)(6) 2021 the patient had amount of bleeding incontinence and burning sensation.The patient was not used one of the defective catheters in almost a week now.Per follow up on (b)(6) 2021 it was stated that the new shipment had a number of catheters which were crimped and almost closed and while inserting the catheter sometimes it gets doubled over.

• Brand Name: BARD® TOUCHLESS® PLUS UNISEX PRE-LUBRICATED VINYL URETHRAL CATHETER
• Common Device Name: TOUCHLESS PLUS CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 11897585
• Report Number: 1018233-2021-03074
• Device Sequence Number: 3710284
• Product Code: FCM
• UDI-Device Identifier: 00801741030604
• UDI-Public: (01)00801741030604
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K910653
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 12/31/2025
• Device Model Number: 4A6144
• Device Catalogue Number: 4A6144
• Device Lot Number: NGEZ2028
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/04/2021
• Supplement Date Received by Manufacturer: 11/11/2021
• Initial Report FDA Received Date: 05/27/2021
• Supplement Report FDA Received Date: 12/01/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/18/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown